WAKO(TM) AUTOKIT URIC ACID

Acid, Uric, Uricase (colorimetric)

WAKO CHEMICALS, USA, INC.

The following data is part of a premarket notification filed by Wako Chemicals, Usa, Inc. with the FDA for Wako(tm) Autokit Uric Acid.

Pre-market Notification Details

Device IDK901544
510k NumberK901544
Device Name:WAKO(TM) AUTOKIT URIC ACID
ClassificationAcid, Uric, Uricase (colorimetric)
Applicant WAKO CHEMICALS, USA, INC. 1600 BELLWOOD ROAD Richmond,  VA  23237
ContactToshihiko Oda
CorrespondentToshihiko Oda
WAKO CHEMICALS, USA, INC. 1600 BELLWOOD ROAD Richmond,  VA  23237
Product CodeKNK  
CFR Regulation Number862.1775 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-04-03
Decision Date1990-05-14

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